Beam re­veals what tripped up its base-edit­ed, off-the-shelf CAR-T as it tries to clear FDA hold

Last month, Beam Ther­a­peu­tics re­vealed the FDA in­tend­ed to place its pre­clin­i­cal off-the-shelf CAR-T ther­a­py on hold. To­day, the com­pa­ny re­vealed the rea­sons why.

Reg­u­la­tors are re­quest­ing four things be­fore they will con­sid­er lift­ing the hold, Beam wrote in an SEC fil­ing, in­clud­ing new da­ta and analy­ses re­gard­ing their ex­per­i­ments’ con­trols and off-tar­get edit­ing. Beam in­tends to re­spond to the hold let­ter, which the com­pa­ny says it re­ceived on Aug. 25, some­time in the fourth quar­ter this year.

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